Senior Regulatory Affairs Associate
Oliver Care at CK Clinical is recruiting for a Senior Regulatory Affairs Associate, EAME Clinical Trial Regulatory Group to join a company in the pharmaceutical industry at their site based in Buckinghamshire on a 12 month fixed-term contract basis.The main purpose of the role will be to:
- Support the operational management of Clinical Trial Applications (CTAs) to regulatory authorities within the EAME region.
- Develop and maintain strong working knowledge of requirements for EAME CTAs, procedures and ICH-GCP and contribute to the EAME Clinical Trial Regulatory Group.
- Build and maintain relationship with Regulatory and Global Drug Development/Operations.
Further responsibilities will include:
- Under supervision, managing clinical trial applications (CTAs) directly to applicable Health Authorities within EAME and supporting CTAs in conjunction with CROs in other relevant countries. You will plan, prepare, co-ordinate & submit CTAs including maintaining the CTA lifecycle and tracking CTA activities.
- Creating and/or maintaining a CTA knowledge database with up to date information of ongoing and completed trials and ensuring effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
- Ensuring that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue-resolution during CTAs.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level in a Life sciences or related field.
- Should have experience in Clinical Trial applications and procedures in EAME region as well as strong working knowledge of European Clinical Trial Applications and procedures.
This is an excellent opportunity to join a multi-speciality, global pharmaceutical company that delivers leading, innovative products.
For more information or to apply for this position, please contact Oliver Care on 01438 842976 or email firstname.lastname@example.org. Alternatively please click on the link below to apply online.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33252 in all correspondence.